Centers for Medicare and Medicaid Services Assigns Permanent J Code for ZUSDURI™ Effective January 1, 2026
UroGen (Nasdaq: URGN) announced that the Centers for Medicare and Medicaid Services assigned a permanent HCPCS Level II J Code J9282 for ZUSDURI (mitomycin) for intravesical solution, effective January 1, 2026.
The code applies to billing in hospital outpatient departments and physician offices and is intended to standardize claims submission, simplify reimbursement processes for providers (subject to individual payor coverage policies), and reduce administrative barriers to patient access for the FDA‑approved treatment for recurrent low‑grade intermediate‑risk non‑muscle invasive bladder cancer.
UroGen (Nasdaq: URGN) ha annunciato che i Centers for Medicare and Medicaid Services hanno assegnato un codice HCPCS Level II J permanente J9282 per ZUSDURI (mitomicina) per soluzione intravescicale, con effetto dal 1 gennaio 2026.
Il codice si applica alla fatturazione nei dipartimenti ambulatori ospedalieri e negli uffici dei medici ed è finalizzato a standardizzare la presentazione delle richieste di rimborso, semplificare i processi di rimborso per i fornitori (soggetti alle politiche di copertura di ciascun assicuratore) e ridurre gli ostacoli amministrativi all’accesso dei pazienti al trattamento approvato dalla FDA per il cancro della vescica ricorrente a basso grado, intermedio rischio non muscolo-invasivo.
UroGen (Nasdaq: URGN) anunció que los Centros de Servicios de Medicare y Medicaid asignaron un código HCPCS de Nivel II J permanente J9282 para ZUSDURI (mitomicina) para solución intravesical, con efecto a partir del 1 de enero de 2026.
El código se aplica a la facturación en departamentos hospitalarios de atención ambulatoria y consultorios médicos y tiene como objetivo estandarizar la presentación de reclamaciones, simplificar los procesos de reembolso para los proveedores (sujeto a las políticas de cobertura de cada aseguradora) y reducir las barreras administrativas para el acceso de los pacientes al tratamiento aprobado por la FDA para el cáncer de vejiga recidivante de bajo grado de riesgo intermedio no muscular invasivo.
UroGen(나스닥: URGN)이 Centers for Medicare and Medicaid Services가 ZUSDURI(mitomycin)용 방광내 용액에 대해 영구적인 HCPCS Level II 코드 J9282를 부여했다고 발표했습니다. 발효일은 2026년 1월 1일부터입니다.
이 코드는 병원 외래 진료 부서와 의사 사무실의 청구에 적용되며, 청구 제출의 표준화를 달성하고 공급자의 상환 절차를 간소화하며(각 보험자의 보장 정책에 따름) FDA 승인 치료인 재발성 저등급 중간 위험 비근육침습성 방광암 환자의 접근성을 높이기 위한 행정적 장애를 줄이는 것을 목표로 합니다.
UroGen (Nasdaq: URGN) a annoncé que les Centers for Medicare and Medicaid Services ont attribué un code HCPCS de niveau II J permanent J9282 pour ZUSDURI (mitomycine) en solution intravésicale, avec effet au 1er janvier 2026.
Le code s’applique à la facturation dans les départements hospitaliers ambulatoires et les cabinets médicaux et vise à standardiser la présentation des réclamations, à simplifier les procédures de remboursement pour les prestataires (soumises aux politiques de couverture de chaque assureur) et à réduire les obstacles administratifs à l’accès des patients au traitement approuvé par la FDA pour le cancer de la vessie récidivant de faible grade à risque intermédiaire non musculo-invasif.
UroGen (Nasdaq: URGN) gab bekannt, dass die Centers for Medicare and Medicaid Services einen permanenten HCPCS Level II J-Code J9282 für ZUSDURI (Mitomycin) als intravesikale Lösung eingeführt haben, der ab dem 1. Januar 2026 gilt.
Der Code gilt für Abrechnungen in Krankenhaus-Ambulanzabteilungen und Arztpraxen und zielt darauf ab, die Einreichung von Ansprüchen zu standardisieren, die Erstattungsprozesse für Anbieter zu vereinfachen (vorbehaltlich der jeweiligen Policys der Kostenträger) und administrative Hürden beim Patientenzugang zu der FDA-genehmigten Behandlung für rezidivierende niedriggradige, mittleres Risiko nicht-muskelinvasiven Blasenkrebs zu senken.
UroGen (Nasdaq: URGN) أعلنت أن مركز خدمات الرعاية الصحية للمسنّين وميديكيد ساعتا أعضاء قد منحوا رمز HCPCS من المستوى II J دائم J9282 لـ ZUSDURI (ميتوميسين) كحَلٍ داخلي للمثانة، اعتباراً من 1 يناير 2026.
ينطبق الرمز على الفوترة في أقسام المستشفيات الخارجية وعيادات الأطباء، ويهدف إلى توحيد تقديم المطالبات وتبسيط إجراءات التعويض للمزودين (وفقاً لسياسات التغطية الخاصة بكل جهة دفع) وتقليل العوائق الإدارية أمام وصول المرضى إلى العلاج المعتمد من FDA لسرطان المثانة المتكرر منخفض الدرجة، عالي المخاطر المتوسط غير الغازي للعضلة.
UroGen（纳斯达克股票代码：URGN）宣布，医疗保险与医疗补助服务中心为 ZUSDURI（丝裂霉素）作为膀胱灌注用溶液分配了永久性的 HCPCS 二级代码 J9282，自 2026 年 1 月 1 日起生效。
该代码适用于医院门诊科室和医生办公室的结算，旨在标准化理赔提交、简化提供者的报销流程（受各自付费方的覆盖政策约束），并降低患者获得 FDA 批准的治疗（用于复发性低级别中等风险、非肌层浸润性膀胱癌）的就医门槛。
- Permanent J Code J9282 assigned, effective Jan 1, 2026
- Standardized billing across hospital outpatient and physician settings
- Expected to simplify reimbursement processes for providers
- Aims to reduce administrative barriers to patient access
- Reimbursement impact limited by individual payor coverage policies
- J Code becomes effective only on Jan 1, 2026, delaying uniform claims use until then
Insights
Permanent CMS J Code J9282 for ZUSDURI standardizes billing and should materially ease reimbursement workflows from
What this does: A permanent HCPCS Level II J Code reduces administrative variability for non-oral oncology drugs by giving providers a single, recognized billing code for ZUSDURI. That simplifies claims creation and can lower coding errors and denials in hospital outpatient departments and physician offices.
Dependencies and caution: The operational benefit depends on individual payor coverage and local payer policy implementations. A J Code does not by itself guarantee coverage, prior authorization changes, or favorable reimbursement rates; those remain subject to payor rules and fee schedules.
Practical outlook and near-term items to watch: Monitor adoption by major Medicare Administrative Contractors and commercial payors after the effective date
PRINCETON, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II J Code, J9282, for ZUSDURI (mitomycin) for intravesical solution, the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The J Code will be effective January 1, 2026, and is intended to facilitate standardized billing and claims submission across hospital outpatient departments and physician office settings.
“Securing a permanent J Code from CMS is an important operational milestone for the ZUSDURI launch,” said Liz Barrett, President and Chief Executive Officer of UroGen. “The new J Code is expected to simplify reimbursement processes for providers across sites of care, subject to individual payor coverage policies. More importantly, it represents another step in ensuring that patients with recurrent LG-IR-NMIBC have streamlined access to this innovative treatment option. By reducing administrative barriers, we are helping physicians focus on delivering care and helping patients access the therapy they need without unnecessary delays or uncertainty.”
A J Code is a specific type of HCPCS Level II code used for billing non-oral medications, such as chemotherapy, immunosuppressant drugs, and inhalation products. The HCPCS is a standardized system used for billing claims for medical supplies, durable medical equipment, and other services not included in the Current Procedural Terminology codes, which handle procedures.
About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product is approved to treat low-grade upper tract urothelial cancer, and our second product, ZUSDURI (mitomycin) for intravesical solution, is approved for adult patients with recurrent LG-IR-NMIBC. Both products are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X, @UroGenPharma.
IMPORTANT SAFETY INFORMATION
APPROVED USE FOR ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove tumor that did not work or is no longer working.
IMPORTANT SAFETY INFORMATION
You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.
Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:
- have kidney problems
- are pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.
Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose. - are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose.
How will I receive ZUSDURI?
- You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions.
- If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
- During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving ZUSDURI:
- ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours.
- To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
- Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, and blood in your urine.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Please see ZUSDURI Full Prescribing Information, including the Patient Information, for additional information.
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the expected benefits of ZUSDURI being assigned a permanent J Code; the estimated annual U.S. patient population and demographics for LG-IR-NMIBC; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs, other than mitomycin; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as “estimate,” “likely,” “expect,” “intend,” “potential,” “up to,” “will” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: clinical results may not be indicative of results that may be observed in the future, including in larger populations; potential safety and other complications related to UroGen’s products; risks related to our and our licensors’ ability to protect our respective patents and other intellectual property; the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s products and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology and ZUSDURI may not perform as expected; new data relating to ZUSDURI, including from spontaneous adverse event reports and from the ongoing ENVISION trial, may result in changes to the product label and may adversely affect sales, or result in withdrawal of ZUSDURI from the market; the potential for payors to delay, limit or deny coverage for ZUSDURI; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 7, 2025, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
INVESTOR CONTACT:
Vincent Perrone
Senior Director, Investor Relations
vincent.perrone@UroGen.com
609-460-3588 ext. 1093
MEDIA CONTACT:
Cindy Romano
Director, Corporate Communications
cindy.romano@UroGen.com
609-460-3583 ext. 1083
FAQ
What J Code did CMS assign to ZUSDURI and when does it take effect for URGN?
How will J9282 affect billing for ZUSDURI in hospital and physician settings for URGN?
Does the J9282 assignment guarantee reimbursement for ZUSDURI (URGN)?
What patient population is ZUSDURI approved to treat for URGN?
Will the J9282 code speed patient access to ZUSDURI for URGN?
Where can providers expect to use J9282 for ZUSDURI starting in 2026?
